Health TrialsbyHealthPanel

Mesenteric Infiltration in Ovarian Cancer

ConditionOvary Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

To evaluate if CT features at diagnosis in patients with HGSOC can be used to build an Artificial Intelligence model capable of discerning the pathological involvement of the mesentery, assessing the potential impediments for an optimal debulking surgery and predicting the development of resistance to platinum based chemotherapeutic agents.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women with confirmed HGSOC wiht mesenteric involvment

Age > 18 years

FIGO STAGE IIIB-IV

Primary diagnosis

Disqualifiers

Non-serous high grade epithelial ovarian cancer (serous low grade, mucinous, clear cell carcinoma, endometrioid or non-epithelial ovarian cancer)

Early stage disease (I and II stage)

CT scan not available

Non-primary diagnosis or patient subjected to neoadjuvant chemotherapy

Trial population

Women with confirmed HGSOC who exhibited mesenteric disease, including mesenteric retraction or diffuse mesenteric carcinomatosis, during diagnostic laparoscopy (or without mesenteric disease for the control cohort)

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Computed Tomography

    Diagnostic test

    Computed Tomography done according to Clinical Practice to assess mesenteric involvment

Treatment groups

510 Participants
are divided into 2 treatment groups
Group A: Retrospective cohort1 intervention
Group B: Prospective cohort1 intervention

Trial outcomes

Primary outcomes

1

Preoperative Artificial Intelligence assisted CT-based evaluation

Preoperative Artificial Intelligence assisted CT-based prediction of patients with suboptimal debulking at surgery due to diffuse mesenteric disease or mesenteric retraction.

Time frame
1 year

Secondary outcomes

1

Evaluation of the Radiologist Assessment of the CT

Identification of mesenteric infiltration from CT images using Artificial Intelligence at a comparable performance with human/radiologist assessment.

Time frame
1 year
2

Prediction of Platinum Resistance

AI-assisted CT-based prediction of patients who will develop platinum resistance

Time frame
1 year
3

Prediction of Progression Free Survival (PFS) and Overall Survival (OS)

Prediction of Progression Free Survival (PFS) and Overall Survival (OS) with Artificial Intelligence

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Danube University Krems

Collaborator

Institut du Cancer de Montpellier - Val d'Aurelle

Collaborator

Ente Ospedaliero Cantonale, Ticino, Switzerland

Collaborator

Source ClinicalTrials.gov
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